EP1677849A1 - Ballonnet utilisable en angioplastie - Google Patents

Ballonnet utilisable en angioplastie

Info

Publication number
EP1677849A1
EP1677849A1 EP04795063A EP04795063A EP1677849A1 EP 1677849 A1 EP1677849 A1 EP 1677849A1 EP 04795063 A EP04795063 A EP 04795063A EP 04795063 A EP04795063 A EP 04795063A EP 1677849 A1 EP1677849 A1 EP 1677849A1
Authority
EP
European Patent Office
Prior art keywords
balloon
surface layer
flexible tube
nitric oxide
pharmaceutically active
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP04795063A
Other languages
German (de)
English (en)
Inventor
Erik Andersen
Daniel Smith
Darrell Reneker
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cube Medical AS
University of Akron
Original Assignee
Cube Medical AS
University of Akron
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cube Medical AS, University of Akron filed Critical Cube Medical AS
Publication of EP1677849A1 publication Critical patent/EP1677849A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12186—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires

Definitions

  • the present invention relates to a balloon for use in angioplasty and its method of manufacture.
  • the balloon may e.g. be suitable for insertion into the vascular system of a living being, for example for expanding an intravascular stent.
  • Angioplasty balloons are often used in various diagnostic procedures and medical treatments.
  • balloons are employed to expand stents for implantation in the lumen of a body duct for the treatment of blood vessels exhibiting stenosis.
  • Stents may contain drugs that after implantation elute to the surrounding tissue as to avoid side effects such as cell proliferation.
  • Expandable stents are often placed on an angioplasty balloon catheter which, once in place, is inflated in order to cause the stent to expand.
  • stents may be made from a material which has a recovery capacity such as a super elastic alloy, such as Nitinol, so that the stents may automatically expand, once in place.
  • Such self expanding stents are often delivered by a telescopic tube arrangement where an outer member is removed e.g. by forced sliding over an inner member to which the stent is fixed prior to expansion.
  • the surfaces of stents should be hydrophilic and have a low surface friction in order to facilitate introduction.
  • the stent surfaces may be coated with a pharmaceutical agent, such as nitric oxide (NO).
  • NO nitric oxide
  • Such nitric oxide releasing matrixes may also relax or prevent arterial spasm once the medical device is in place.
  • Nitric oxide is further known to inhibit the aggregation of platelets and to reduce smooth muscle proliferation, which is known to reduce restenosis. When delivered directly to a particular site, it has been shown to prevent or reduce inflammation at the site where medical personnel have introduced foreign objects or devices into the patient.
  • 6,737,447 Bl discloses a medical device comprising at least one nanofiber of a linear poly(etihylenimine) diazeniumdiolate forming a coating layer on the device. This polymer is effective in delivering nitric oxide to tissues surrounding medical device.
  • the invention provides an expandable balloon for use in angioplasty procedures, comprising a balloon having an outer surface layer, the outer surface layer being made from electrospun nanofibers and incorporating at least one pharmaceutically active substance.
  • the invention provides a method of producing a balloon for use in angioplasty, the method comprising the step of forming an outer surface layer for the balloon by electrospinning of nanofibers, the outer surface layer containing at least one pharmaceutically active substance.
  • the body portion and the outer surface layer may, for example, define an expandable coated angioplasty balloon, such as a PTA (percutaneous translumenal angioplasty) balloon, a PTCA (percutaneous translumenal coronar angioplasty) balloon or a PTNA (percutaneous translumenal neurovascular angioplasty catheter).
  • an expandable coated angioplasty balloon such as a PTA (percutaneous translumenal angioplasty) balloon, a PTCA (percutaneous translumenal coronar angioplasty) balloon or a PTNA (percutaneous translumenal neurovascular angioplasty catheter).
  • the outer surface layer is one which conforms to the shape of the balloon, i.e. expands with the balloon when the balloon is inflated and contracts when the balloon is deflated.
  • the outer surface layer is preferably made from a polymer which will be described in further detail below.
  • the diameter of the nanofibers is in the range of 2 to 4000 nanometers, preferably 2 to 3000 nanometers, and accordingly a large number of nanofibers is present on the outer surface of the balloon.
  • the nanofibers on the outer surface of the balloon define a large accumulated area, the area being larger with respect to the weight of the balloon than what is achievable with most other non-electrospun surfaces.
  • the electrospun surface constitutes a relatively large reservoir for the pharmaceutically active substance compared to the weight of the coated balloon.
  • Nanofibers may even be manufactured to a diameter of 0.5 nanometer which is close to the size of a single molecule.
  • the present invention allows for the manufacture of balloons with relatively low diameters which, in comparison to devices with larger diameters, facilitate introduction into the vascular system of a living being and reduce side-effects which may occur as a consequence of the introduction of the balloon.
  • the spinning of nanofibers allows for the manufacture of integrated composite devices, in which two or more materials are interlocked on a molecular scale in small dimensions while maintaining a sufficient mechanical stability. Cross-sectional dimensions as small as the dimension of approximately 2-5 molecules of the spun material may be achieved. The size of the molecules evidently depends from the source material used, the size of a polyurethane molecule being usually in the range of less than 3000 nanometers.
  • electrospinning comprises a process wherein particles are applied onto a base element which is kept at a certain, preferably constant, electric potential, preferably a negative potential.
  • the particles emerge from a source which is at another, preferably positive potential.
  • the positive and negative potentials may e.g. be balanced with respect to the potential of a surrounding environment, i.e. a room in which the process is being performed.
  • the potential of the base element with respect to the potential of the surrounding atmosphere may preferably be between -5 and -30 kV, and the positive potential of the source with respect to the potential of the surrounding atmosphere may preferably be between +5 and +30 kV, so that the potential difference between source and base element is between 10 and 60 kV.
  • US patent No. 6,382,526 discloses a process and apparatus for the production of nanofibers, which process and apparatus are useful in the method according to the present invention
  • US patent No. 6,520,425 discloses a nozzle for forming nanofibers. It should be understood that the processes and apparatuses of the aforementioned US patents may be applicable in the method according to the present invention, but that the scope of protection is not restricted to those processes and apparatuses.
  • the balloon may be produced by the present invention may define a plurality of sections along its length.
  • the sections may have different properties, such as different hardness.
  • Such different properties may be arrived at by employing different fiber-forming materials for different sections and/or by changing production parameters, such as voltage of electrodes in the electrospinning process, distance between high-voltage and low-voltage electrodes, rotational speed of the device (or of a core wire around which the device is manufactured), electrical field intensity, corona discharge initiation voltage or corona discharge current.
  • the body part of the balloon may for example be made of a polyamide material, such as Nylon-12 or TicoflexTM or a combination thereof.
  • the balloon body may be made from Nylon-12 provided with a coating a TicoflexTM, onto which the outer surface layer is formed by electrospun nanofibers.
  • TicoflexTM may be used directly as a polymer used for forming the nanofibers.
  • balloons produced by preferred embodiments of the method according to the invention have a low surface friction.
  • a low surface friction may be achieved by applying a hygroscopic material as a fiber forming material for the electrospinning process. Accordingly, once introduced into the vascular system, the hygroscopic electrospun material absorbs bodily fluid, resulting in a hydrophilic low-friction surface.
  • a hygroscopic surface may for example be achieved with a polyurethane or a polyacrylic acid material.
  • the outer surface layer of the balloon may constitute a reservoir to drugs.
  • the electrospun portions thereof constitute reservoirs for holding drugs or constitute a matrix polymer source where the drug is either blocked into the molecule chain or adheres to or surrounds the molecule chain.
  • the balloons disclosed herein may carry any appropriate drug, including but not limited to nitric oxide compositions, heparin and chemotherapeutical agents.
  • the outer surface layer of the expandable balloon is made from electrospun fibres which incorporate at least one pharmaceutically active substance.
  • the electrospun fibres form a polymer matrix of one or more polymers.
  • the "outer surface layer made from electrospun fibres, i.e. the polymer matrix needs not to be the outermost layer of the balloon, for example a layer of a hydrophilic polymer (e.g. polyacrylic acids (and copolymers), polyethylene oxides, poly(N-vinyl lactams such as polyvinyl pyrrolidone, etc.) may be provided as a coating on the outer surface layer (polymer matrix).
  • a hydrophilic polymer e.g. polyacrylic acids (and copolymers), polyethylene oxides, poly(N-vinyl lactams such as polyvinyl pyrrolidone, etc.
  • a barrier layer may be provided as coating on the outer surface layer (polymer matrix) in order to ensure that contact between the polymer matrix and blood is delayed until the expandable balloon is in place.
  • the barrier layer may either be formed of a biodegradable polymer which dissolves or disintegrates, or the barrier layer may be disintegrate upon inflation of the balloon.
  • polymer matrix is meant the three-dimensional structure formed by the electrospun fibers. Due to the nature of the electrospinning process, the polymer matrix is characterized by a very high accessible surface area which allows swift liberation of the pharmaceutically active substance(s).
  • the polymer of the polymer matrix may be prepared from various polymer-based materials and composite matrixes thereof, including polymer solutions and polymer melts. Applicable polymers are, e.g., polyamides including nylon, polyurethanes, fluoropolymers, polyolefins, polyimides, polyimines, (meth)acrylic polymers, and polyesters, as well as suitable co-polymers. Further, carbon may be used as a fiber- forming material.
  • the polymer matrix is formed of one or more polymers and may - in addition to the pharmaceutically active substance(s) - incorporate or comprise other ingredients such as salts, buffer components, microparticles, etc.
  • incorporación at least one pharmaceutically active substance is meant that the pharmaceutically active substance(s) is/are either present as discrete molecules within the polymer matrix or is/are bound to the polymer(s) of the matrix either by covalent bonds or by ionic interactions. In the latter of the two instances, the pharmaceutically active substance(s) typically needs to be liberated from the polymer molecules before the biological effect can enter into effect. Liberation will often take place upon contact with physiological fluids (e.g. blood) by hydrolysis, ion-exchange, etc.
  • physiological fluids e.g. blood
  • the pharmaceutically active substance is covalently bound to polymer molecules.
  • the pharmaceutically active substance may be mixed into a liquid substance from which the outer surface layer is manufactured.
  • the pharmaceutically active substance is a nitric oxide donor.
  • nitric oxide is released into the body tissue in the gas phase immediately upon placement of the balloon at the treatment site, or within 5 minutes at most from its placement. As nitric oxide is released in the gas phase, it may be achieved that no or only few residues of the NO donor are deposited in the tissue.
  • NONO 'ates are applied as nitric oxide donors. NONO'ates break down into the parent amine and NO gas in an acid catalyzed manner, according to the below figure, cf. US 6147068, Larry K. Keefer: Methods Enzymol, (1996) 268, 281-293, and Naunyn-Schmeideberg ' s Arch Pharmacol (1998) 358, 113-122.
  • NO is released within the electrospun polymer matrix.
  • water may enter into the matrix.
  • the NO molecule can be transported out of the matrix and into the tissue in a number of ways and combinations hereof. In the following some scenarios are described: NO becomes dissolved in water within the matrix and transported out of the matrix by diffusion or by water flow; NO diffuse out of the matrix in gas form and becomes dissolved in water outside the matrix; NO diffuses from water into the tissue; NO diffuses all the way from the matrix in gas form into the tissue.
  • the rate of NO liberation highly depends on the pH of the media.
  • the rate of NO liberation can be controlled.
  • Ascorbic Acid can be used as an acidic agent for enhancing release of NO.
  • nitric oxide (NO) donor compounds and polymeric compositions capable of releasing nitric oxide have also been proposed in the prior art, e.g. US 5,691,423, US 5,962,520, US 5,958,427, US 6,147,068, and US 6,737,447 Bl (corresponding to EP 1220694 Bl), all of which are incorporated herein by reference.
  • the nanofibers are made from polymers which have nitric oxide donors (e.g. a diazeniumdiolate moiety) covalently bound thereto.
  • nitric oxide donors e.g. a diazeniumdiolate moiety
  • Polyimines represent a diverse group of polymer which may have diazeniumdiolate moieties covalently bound thereto.
  • Polyimines include poly(alkylenimines) such as poly(ethylenimines).
  • the polymer may be a linear poly(ethylenimine) diazeniumdiolate (NONO-PEI) as disclosed in US 6,737,447 which is hereby incorporated by reference.
  • NONO-PEI linear poly(ethylenimine) diazeniumdiolate
  • the loading of the nitric oxide donor onto the linear poly(ethylenimine) (PEI) can be varied so that 5-80%, e.g. 10-50%, such as 33%, of the amine groups of the PEI carry a diazeniumdiolate moiety.
  • the linear NONO-PEI can liberate various fractions of the total amount of releasable nitric oxide.
  • Polyamines with diazeniumdiolate moieties may advantageously be used as a polymer for the electrospinning process because such polymers typically have a suitable hydrophilicity and because the load of diazeniumdiolate moieties (and thereby the load of latent NO molecules) can be varied over a broad range, cf. the above example for NONO-PEI.
  • the pharmaceutically active substance(s) is/are present within the polymer matrix as discrete molecules.
  • the pharmaceutically active substance(s) may be contained in microparticles, such as microspheres and microcapsules.
  • microparticles are in particular useful in the treatment of cancer.
  • the microparticles may be biodegradable and may be made from a biodegradable polymer such as a polysaccharide, a polyamino acid, a poly(phosphorester) biodegradable polymer, a polymers or copolymers of glycolic acid and lactic acid, a poly(dioxanone), a poly(trimethylene carbonate)copolymer, or a poly( ⁇ -caprolactone) homopolymer or copolymer.
  • a biodegradable polymer such as a polysaccharide, a polyamino acid, a poly(phosphorester) biodegradable polymer, a polymers or copolymers of glycolic acid and lactic acid, a poly(dioxanone), a poly(trimethylene carbonate)copoly
  • the microparticles may be non-biodegradable, such as amorphous silica, carbon, a ceramic material, a metal, or a non-biodegradable polymer.
  • microparticles may be in the form of microspheres that encapsulate the pharmaceutically active substance, such as the chemotherapeutic agent.
  • the release of the pharmaceutically active substance preferably commences after the administration.
  • the encapsulating microspheres may be rendered leaky for the pharmaceutically active substance by means of an electromagnetic or ultrasound shock wave.
  • a hydrophilic layer is preferably applied to the outer surface layer.
  • the hydrophilic layer may be provided as a separate layer of material.
  • the outer surface layer may itself exhibit hydrophilic properties.
  • the outer surface layer may advantageously include an acidic agent, such as lactic acid or vitamin C, which acts as a catalyst for releasing the pharmaceutically active substance, e.g. nitric oxide.
  • the acidic agent is capable of changing the ph-value at the treatment site, the release rate of nitric oxide at the treatment site varying as a function of the local ph-value.
  • the presence of vitamin C may boost the nitric oxide release, i.e. provide a shock-like release of nitric oxide.
  • nitric oxide In general, the release of nitric oxide is described in Prevention of intimal hyperplasia after angioplasty and/or stent insertion. Or, How to mend a broken heart by Jan Harnek MD, Heart Radiology, University of Lund, Sweden, 2003.
  • the pharmaceutically active substance may be provided in the form of biodegradable headings distributed between the nanofibers, the headings being capable of releasing the pharmaceutically active substance and, in the case of biodegradable headings, to degrade following release.
  • Such headings which are described in more detail in international patent application No. PCT/DK2004/000560 which is hereby incorporated by reference in its entirety, may penetrate into the tissue at the treatment site and release the pharmaceutically active substance there. Alternatively, they may be of a size which is so small that they may be transported away, e.g. with the flow of blood, away from the treatment site.
  • the outer surface layer may be formed on a separate flexible tube or "sock" which is slipped over the balloon. Accordingly, various flexible tubes having various properties or incorporating various pharmaceutically active substances may be inexpensively manufactured and slipped over traditional, mass manufactured balloons.
  • the flexible tube may be formed by providing a core element, such as a mandrel, onto which the nanofibers are deposited by electrospinning as the mandrel is continuously rotated.
  • the flexible tube In an unexpended state of the balloon, the flexible tube may be folded around, so that the flexible tube, when seen in cross-section, defines a spoke-and-hub-formation.
  • the balloon body may be covered by an intermediate polymer layer, such as a TicoflexTM layer, before it is being coated.
  • the intermediate layer may be formed by dip-coating the balloon body.
  • the intermediate layer may alternatively be formed by a polyurethan or by the polymer which is also used for the outer surface coating, e.g. a linear poly(ethylenimine) diazeniumdiolate as disclosed in US 6,737,447 Bl.
  • Dip coating is known per se. For example, dip coating is used in the rubber industry for the manufacture of latex products, and co- extrusion is e.g. applied in the manufacture of fibre-optics cables. Braiding may be employed as an alternative to dip-coating for achieving a roughened or textured surface.
  • nitric oxide may be applied to the outer surface layer by exposing the outer surface layer to nitric oxide in a chamber containing pressurized nitric oxide at a pressure of, e.g. 1-5 bar, or 1.5 - 5 bar, or 2-5 bar.
  • the nitric oxide may be applied in the expanded state of the balloon, i.e. when the balloon is inflated by pressurized gas or liquid.
  • the tube is preferably supported by a core member, such as a steel wire, extending through the flexible tube when the tube is exposed to pressurized nitric oxide.
  • the NO may be applied to the flexible tube when it is slipped over the balloon, in which case the balloon is preferably inflated when NO is applied in the pressure chamber.
  • the step of electrospinning nanofibers usually comprises feeding a fiber-forming material through a dispensing electrode arranged at a distance from a supporting element, whereby a plurality of strands of the fiber-forming material emerge out of said dispensing electrode.
  • the properties of the outer surface layer are controlled by controlling the fluidity of said strands when they reach the supporting element, for example by controlling the distance between the dispensing electrode and the supporting element.
  • the fluidity of the jet By controlling the fluidity of the jet, the crossing fibers can be made into a multiply connected network which is unlikely to unwind if the network broke at only one point.
  • the fluidity may enable the more fluid fibers to conform closely to the shape of the balloon or any other supporting element used in the electrospinning process everywhere the fibers contact the balloon or supporting element.
  • the invention provides a method of treating cell disorders, such as inflammation, proliferation or cancer, in tubular structures of a living being, comprising the steps of:
  • the step of releasing the pharmaceutically active substance may be controlled by the presence of a ph-controlling substance incorporated in the outer surface layer, e.g. an acidic agent, such as C vitamin (ascorbic acid) or lactic acid.
  • a ph-controlling substance e.g. an acidic agent, such as C vitamin (ascorbic acid) or lactic acid.
  • an unexpanded stent may be placed on the balloon, which stent may be placed at the treatment site along with the balloon.
  • the stent is subsequently expanded at the treatment site as the balloon is being expanded, and finally the balloon is deflated and removed from the tubular structure while the stent is left at the treatment site.
  • the invention also provides a kit comprising a coated balloon as described above, a stent and optionally a guide wire for guiding the stent to the treatment site.
  • Figs. 1-6 are step-by-step illustrations of a preferred embodiment of a method for producing a medical tubing, e.g. a tubular member for an embodiment of a balloon according to the present invention
  • Fig. 7 shows an embodiment of an angioplasty balloon catheter comprising a balloon according to the present invention
  • Figs. 8 and 9 illustrate folding of a balloon.
  • the nanofibers are spun onto an outer surface of a core member.
  • the core member comprises a core wire (or mandrel) 100, a layer 102 of PTFE applied to an outer surface of the core wire, a coating 104 of a thermoplastic material applied to an outer surface of the PTFE layer 102, and at least one reinforcing wire 106 applied to an outer surface of the thermoplastic coating, with the filaments of electrospun nanofibers being provided as an outer layer 108, i.e. enclosing the reinforcing wire and the thermoplastic coating.
  • a hydrophilic layer 110 is optionally applied to an outer surface of the device, cf. Fig. 6.
  • the diameter of the guide wire may be at least 0.1 mm, such as in the range of 0.1 to 1.0 mm or larger.
  • the thermoplastic coating which is preferably a coating of polyurethane (PU), preferably has a thickness of 5 ⁇ m to about 0.05 mm, preferably 0.01 mm ⁇ 20%.
  • the reinforcing wire(s) preferably has/have a diameter of 5 ⁇ m to about 0.05 mm, preferably 0.01 mm ⁇ 20%.
  • a layer of PTFE 102 may be applied to an outer surface of the core member 100. At least a portion of the surface of the layer of PTFE, such as the portion onto which the nanofibers and/or the thermoplastic coating are to be applied, may be modified for improved bonding of material to the outer surface of the PTFE layer. Preferably, such modifying comprises etching, which may for example result in a primed PTFE surface for covalent bonding or gluing. Etching may be achieved by applying a flux acid or hydroflouric acid to a surface of the PTFE layer.
  • the layer of PTFE may be provided as a hose which is slipped over and co-extends with the core wire.
  • a coating of a thermoplastic material 104 such as polyurethan (PU) may be provided to an outer surface of the core member 100, i.e. to an outer surface of the PTFE layer 102 in case such a layer has been provided.
  • a thermoplastic material 104 such as polyurethan (PU)
  • PU polyurethan
  • one or more reinforcing wires 106 may be applied to an outer surface of the core member 100, i.e., in a preferred embodiment, to an outer surface of the polyurethane coating 104.
  • the reinforcing wire(s) may consist of one or wires made from steel or/and wires made from yarn, such as carbon filament, which may be applied by winding.
  • the reinforcing wire may be applied by spinning of nanofibers, preferably by electrospinning as described above.
  • the electrospun reinforcing wire may be formed from carbon or polymer, including polymer solutions and polymer melts.
  • Applicable polymers are: nylon, fluoropolymers, polyolefins, polyimides, and polyesters.
  • the core member 100 is preferably rotated, so as to evenly distribute the nanofibers around the outer surface of the core member.
  • nanofibers 108 are applied to the outer surface of the core member at this stage, that is preferably to the outer surface of the thermoplastic coating 104 which is optionally reinforced by the reinforcing wire(s).
  • the electrospinning process is discussed in detail above.
  • a solvent such as tetrahydroforane (THF) or isopropanol alcohol (IPA), may subsequently be applied to an outer surface of the core member, the outer surface being defined by the electrospun portion (or layer) 108 of the device.
  • the thermoplastic coating 104 thereby at least partially dissolves in the solvent, so as to bond the reinforcing wire(s) 106 thereto.
  • the reinforcing wire(s) 106 thereby become(s) embedded in the thermoplastic coating 104. It has been found that the step of providing the solvent results in a highly dense surface with a low surface friction, which is believed to be due to crumpling or shrinking of stretched molecules of electrospun nanofibers once the solvent is applied.
  • the core wire 100 (or mandrel) is removed from the device following the step of applying the solvent or prior to the step of applying solvent but subsequent to the step of applying the filament of electrospun nanofibers 108.
  • the resulting tubular member may be used as a flexible tube or sock which may be slipped over a balloon.
  • nanofibers may be formed directly onto the balloon by electrospinning, the balloon being optionally coated, e.g. dipcoated, or braided as discuseed above to enhance adhering of the nanofibers to its surface.
  • Fig. 7 shows different embodiments of an angioplasty balloon catheter comprising a balloon in accordance with the present invention.
  • an inflated balloon 118 which comprises an outer surface layer 120 made from electrospun nanofibers.
  • the balloon is carried by a guidewire 122.
  • Fig. 11 shows a non-inflated balloon 124 over which there is slipped a tube or "sock" 126 made from electrospun nanofibers.
  • the dashed lines show the contour of the balloon 124 and the sock 126 when the balloon is inflated.
  • Figs. 12 and 13 are schematic illustrations of an unexpanded state of a balloon, wherein a flexible tube is folded, so that the flexible tube, when seen in cross-section, defines a spoke- and-hub-formation.

Abstract

L'invention concerne un ballonnet gonflable destiné à être utilisé dans des procédures d'angioplastie, qui comprend: un ballonnet présentant une couche superficielle extérieure constituée de nanofibres électriquement filées et incorporant au moins une substance pharmaceutiquement active, telle que le monoxyde d'azote (NO). La couche superficielle extérieure peut être formée sur un élément tubulaire souple séparé ou sur une chaussette glissée au-dessus du ballonnet. Un agent acide, tel que l'acide ascorbique, peut être introduit dans le ballonnet pour accélérer la libération de NO. Une méthode de traitement de troubles cellulaires dans des structures tubulaires d'un être vivant consiste à: placer un ballonnet enduit dans des structures tubulaires, sur un site de traitement; gonfler le ballonnet sur le site de traitement; et libérer la substance pharmaceutiquement active sur le site de traitement. Facultativement, un tuteur peut être forgé sur le ballonnet préalablement à l'insertion du ballonnet et du tuteur dans les structures tubulaires de l'être vivant.
EP04795063A 2003-10-14 2004-10-14 Ballonnet utilisable en angioplastie Withdrawn EP1677849A1 (fr)

Applications Claiming Priority (7)

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US51052003P 2003-10-14 2003-10-14
DKPA200301514 2003-10-14
US52962903P 2003-12-16 2003-12-16
DKPA200301864 2003-12-16
US56608704P 2004-04-29 2004-04-29
DKPA200400671 2004-04-29
PCT/US2004/033851 WO2005037339A1 (fr) 2003-10-14 2004-10-14 Ballonnet utilisable en angioplastie

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EP04795063A Withdrawn EP1677849A1 (fr) 2003-10-14 2004-10-14 Ballonnet utilisable en angioplastie

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EP (2) EP1691856A2 (fr)
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WO2005039664A3 (fr) 2005-06-30
WO2005039664A2 (fr) 2005-05-06
WO2005037339A1 (fr) 2005-04-28
WO2005037339A9 (fr) 2005-10-13
JP2007508121A (ja) 2007-04-05
US20070255206A1 (en) 2007-11-01
US20070207179A1 (en) 2007-09-06
EP1691856A2 (fr) 2006-08-23

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